Trial Information

Analyses of c-Myc (MYC) and Topoisomerase II Alpha (TOP2A) Copy Number Aberrations; MYC, Insulin-like Growth Factor Receptor-1 (IGF-1R) and PTEN Protein Expressions; and Phosphatidylinositol 3' Kinase (PIK3) Gene Mutations in N9831 Primary Breast Tumors

OBJECTIVES:

Primary

- To determine the association between the primary breast tumor protein expression of
MYC, IGF-1R, and PTEN and disease-free survival (DFS) in patients randomized on
clinical trial NCCTG-N9831.

- To determine the association between the primary breast tumor amplification status of
MYC and TOP2A and DFS in patients randomized on NCCTG-N9831.

- To determine the association between the primary breast tumor mutation status of PIK3
and DFS in patients randomized on NCCTG-N9831.

Secondary

- To determine the association between the primary breast tumor marker protein
expression/amplification/mutation status of the aforementioned markers and overall
survival in patients randomized on NCCTG-N9831.

- To investigate the predictive potential of multiple marker analyses on DFS and overall
survival using multivariate analysis.

- To determine the correlation between the protein expression and amplification status of
MYC in patients randomized on NCCTG-N9831.

- To determine the correlation between marker protein expression/amplification/mutation
status and known clinicopathological characteristics of the tumors.

OUTLINE: This is a multicenter study.

Tissue samples from protocol NCCTG-N9831 are obtained for immunohistochemistry and
fluorescence in situ hybridization analysis of MYC, IGF- 1R, PTEN, and TOP2A genes. Exons 9
and 20 of PIK3CA gene are amplified via polymerase chain reaction; mutations in exons 9 and
20 of PIK3CA gene are identified.